Kornimate/medical-research-clean huggingface dataset:
a clinical study on the safety and efficacy of debio 0932 in combination with standard of care in patients with non-small cell lung cancer [nsclc]

Conditions: Non-small Cell Lung Cancer

Summary: part a of this study will investigate the maximum tolerated dose of debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced nsclc.

part a of this study will determine the maximum tolerated dose of debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with stage iiib or iv nsclc, and with docetaxel in previously treated patients with stage iiib or iv nsclc. escalating doses of debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.

Eligibility criteria:
inclusion criteria: * diagnosis of nsclc with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (egfr) mutation * advanced or metastatic disease (stage iiib or iv) * patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: no previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if \> 6 months ago); patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy * measurable disease by the response evaluation criteria in solid tumors (recist) criteria * ecog performance score 0-1 * life expectancy ≥ 3 months * adequate bone marrow-, renal- and hepatic function * lvef ≥ 55% on cardiac ultrasound exclusion criteria: * symptomatic brain metastases * gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, crohn's disease) * concurrent treatment with any other systemic anti-cancer therapy * serious concomitant uncontrolled medical conditions

Keywords: safety efficacy hsp90 debio 0932 standard of care treatment, nsclc
usability, immediate, and 30 day effect of external neuromodulation with itear100 generation 2 in dry eye patients

Conditions: Dry Eye

Summary: itear generation 2 will be supplied t eligible subjects at day 0. at day 30, symptom questionnaires and ophthalmic exam will be performed.

tear generation 2 will be supplied t eligible subjects at day 0. at day 30, symptom questionnaires and ophthalmic exam will be performed. at both exam days, a schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.

Eligibility criteria:
inclusion criteria: * dry eye exclusion criteria: * unable to read consent * investigator discretion
the natural history of recovery after stroke

Conditions: Cerebral Vascular Accident (CVA)/Stroke

Summary: the goal of this longitudinal observational study is to learn the course of recovery after stroke. specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.

this study constitutes the first step in the restro project: evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. in this study, we will monitor sensorimotor and cognitive functions of stroke patients along the first 6 to 12 month following their stroke. data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested.

Eligibility criteria:
inclusion criteria: * \>18 years of age * independent in all activities of daily living before the stroke. * in- and out-patients at adi-negev nahalat-eran rehabilitation center, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in adl before the second stroke). * medically stable * able to provide informed consent. exclusion criteria: * the presence of any degenerative neurological condition, neuropathy, myopathy or polio that are not secondary to stroke, excluding diabetic related changes. * traumatic brain injury and/or extra-cerebral hemorrhage. * significant psychiatric condition, including alcoholism and drug abuse. * any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome. * participation in another interventional study.
safety and efficacy of balloon pulmonary angioplasty in china

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: balloon pulmonary angioplasty (bpa) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (cteph). the aim of this study was to evaluate the safety and efficacy of bpa in cteph patients not amenable to pulmonary endarterectomy(pea) or suffered from persistent cteph after pea.

this study is a prospective, multi-center, long-term observational project to study the safety and efficacy of bpa. clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of bpa, and 3-12 months after last session of bpa. we also aim to evaluate the value of fapi in predicting the efficacy and the prognosis of patients with cteph who received bpa.

Eligibility criteria:
inclusion criteria: 1. diagnosed with cteph according to esc guidelines (1) mean pap ≥ 25mmhg at rest; or if mean pap \< 25mmhg at rest, have exercise limitations from chronic thromboembolic disease (2)abnormal ventilation perfusion lung scanning (vq) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. treatment with anticoagulation for ≥ 3 months before diagnosis of cteph 3. not amenable to pulmonary endarterectomy 4. willing to provide informed consent exclusion criteria: 1. patients unwilling or unable to provide written consent for participation in the study. 2. impossible to follow up.
the efficacy and safety of kn046 combined with axitinib

Conditions: NSCLC

Summary: evaluation of the efficacy of kn046 combined with acitinib as a neoadjuvant therapy for resectable nsclc through primary pathological response rate and surgical resection rate

the purpose of this study is to evaluate the rate of major pathological remission (mpr) with preoperative use of kn046 versus axitinib, and thus to assess the efficacy of kn046 in combination with axitinib in patients with stage ib-iiib (stage iiib only t3n2m0) nsclc (according to the 8th edition of the ajcc classification) who are scheduled to undergo surgery. eligible subjects for this study were candidates for surgery for resectable stage ib-iiib (stage iiib only t3n2m0) nsclc as judged by the investigator, with no evidence of distant metastases as assessed, and no evidence of unresectable local regional tumour extension.

Eligibility criteria:
inclusion criteria: 1. the subject is at least 18 years old and\<75 years old on the day of signing the informed consent form, regardless of gender, and is willing to follow the research procedure; 2. confirmed by histology or cytology as non-small cell lung cancer; 3. nsclc patients evaluated by researchers as resectable in stage ib-iiib (stage iiib only limited to t3n2m0) (ajcc 8th edition); 4. has not received any anti-tumor treatment in the past, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy; 5. no allergenic egfr mutation or alk change; 6. the ecog score is 0-1 points. exclusion criteria: 1. the lesion of squamous non-small cell lung cancer presents as a central type of lung cancer accompanied by cavity formation or invasion of blood vessels, with a high risk of hemoptysis; 2. previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy; 3. previous history of allogeneic bone marrow or organ transplantation; 4. subjects who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment within 28 days before the administration of this trial; 5. prior to allocation, they have received systemic anti-cancer treatment, including research drugs targeting current malignant tumors; 6. other known malignant tumors are progressing or require active treatment within the past 5 years. note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have received possible radical treatment are not excluded; 7. pregnant and/or lactating women.

Keywords: kn046 axitinib neoadjuvant
zona pellucida bound sperm vs. embryologist selected sperm for intracytoplasmic sperm injection

Conditions: Infertility

Summary: this study aims to assess the clinical significance of the intracytoplasmic sperm injection (icsi) with zona-pellucida (zp) bound sperm compared to icsi with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.

in this study, the investigators aim to determine the clinical utility of the zp-bound sperm selection methodology for icsi. this study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for icsi via the embryologist versus sperm selected via zp-binding for icsi. embryology, ploidy and clinical pregnancy outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * undergoing their first in vitro fertilization (ivf) cycle * electing single embryo transfer * electing preimplantation genetic testing for aneuploidy (pgt-a) of their embryos * female partners age \ 18 years old. * normal ovarian reserve: * antimullerian hormone level (amh) ≥ 1.2 ng/ml * antral follicle count (afc) ≥ 8 * at least 4 mature oocytes (m2s) retrieved at the vor procedure in order to randomize * at least 1 immature oocyteretrieved at the vor procedure to perform zp binding co-incubation procedure * intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure exclusion criteria: * contraindication to ivf * clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis) * male partner with azoospermia or oligozoospermia (\<100,000 total motile spermatozoa) * male partner with y-chromosome microdeletion * male partner with any karyotype other than 46,xy * male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures * uncorrected hydrosalpinges that communicate with the endometrial cavity * endometrial insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid * donor oocyte cycles * gestational carriers

Keywords: intracytoplasmic sperm injection procedure icsi
effects of nutritional support on postoperative delirium

Conditions: Postoperative Delirium

Summary: this study is a prospective, single-center, randomized controlled trial to compare whether applying nutritional supplementation therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium.


Eligibility criteria:
inclusion criteria: * elderly patients aged 65 and above. * patients undergoing non-cardiac major surgery in thoracic surgery, lung cancer surgery, multi-level spinal surgery in neurosurgery and orthopedics, or liver cancer surgery in hepatobiliary and pancreatic surgery, under general anesthesia with an expected surgery duration of 2 hours or more. * patients scheduled for arterial catheterization. * patients who are able to take oral intake from postoperative day #1. exclusion criteria: * patients with uncontrolled systemic conditions such as diabetes, hypertension, renal disease, liver disease, and other systemic illnesses. * those with visual impairment. * patients with cognitive impairment based on the mini-mental state examination for dementia screening criteria. * individuals experiencing difficulty in communication. * those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, parkinson's disease, cognitive impairment, depression, etc.). * patients diagnosed with alcohol or substance addiction. * patients with cancelled scheduled surgeries. * patients undergoing minor surgeries with expected anesthesia durations of less than 2 hours.
study of blood, tumor and adjacent normal tissue samples from chinese smoking induced lung cancer patients

Conditions: Non Small Cell Lung Cancer

Summary: this is an epidemiological,multicenter study of genomic and expression profiles of patients with newly diagnosed nsclc.two hundred and fifty nsclc patients who fulfill the criteria are to be recruited by investigational sites.approximately 100 of them will be from retrospectively collected samples with detailed clinical and 2-year follow-up information after surgeries.the demographics,cancer/adjacent normal tissue and matched blood sample will be collected after the patient had provided informed consent.all tissue samples will be analyzed for somatic mutations by exome deep sequencing,mrna expression profiling by rna sequencing and chromosome copy number variation by snp array at the designated laboratories.

the 2-year follow-up information of all enrolled patients will be collected every 6 months.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent. 2. male or female aged≥18 years. 3. .histological or cytologically confirmed primary nsclc，including histological subtypes:adenocarcinoma,squamous cell carcinoma and large cell carcinoma etc. 4. .provision of surgical specimen and blood sample.the retrospective samples will be collected between 2006and 2012 from the bio-bank. 5. patients must be willing to provide detailed clinical information (sex,age,geographic place,tumor stage,grade,size,smoking history,treatment history if any and outcome data). 6. heavy smokers(defined as having smoked 20 pack-years or more). 7. treatment naive patients:no prior chemotherapy,biological,immunological therapy or radical radiotherapy is permitted. exclusion criteria: * not applicable

Keywords: non small cell lung cancer heavy smokers treatment naive patients
evaluation of brain changes in all patients on therapy

Conditions: Acute Leukemia

Summary: the study is aimed at assessing changes in the brain of patients from 6 to 18 years old with a diagnosis of acute lymphoblastic leukemia during chemotherapy.

children with acute lymphoblastic leukemia receive long-term combined chemotherapy treatment, one of the main part of this treatment is methotrexate. methotrexate can cause acute, subacute, and long-term neurotoxicity. clinical symptoms of neurotoxicity, such as seizures, aphasia, are often associated with leukoencephalopathy. however, leukoencephalopathy may develop asymptomatically in children receiving methotrexate. the effect of chemotherapy on the neurological status of patients is widely covered in the literature. there are very few studies devoted to the quantitative assessment of mri parameters, especially in children. mri is a non-invasive method that does not harm the patient and can be used to assess absolutely all structures of the brain.

Eligibility criteria:
inclusion criteria: 1. patients from 6 to 18 years old 2. diagnosis of acute lymphoblastic leukemia during chemotherapy exclusion criteria: 1. patients less then 6, and older then 18 years old 2. patients who cannot perform the study mri without general anesthesia 3. refusal to sign informed consent. 4. the presence of absolute contraindications to mri studies. 5. extremely serious condition of the patient.

Keywords: quantitative mri acute lymphoblastic leukemia neurotoxity children
dose escalation trial of denileukin diftitox (ontak) post autologous transplantation

Conditions: Multiple Myeloma

Summary: the primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (dd) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. secondary goals include evaluating the the effect of dd on the number and percentage of t-regs in the peripheral blood post transplant at each dose level, the effect of dd on t cell (cd4/cd8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/l for 3 consecutive days), and platelet (\>20x 10\^9/l for 3 consecutive days). the hypothesis for the study is based on the ability of dd to deplete t-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. this may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.


Eligibility criteria:
inclusion criteria: all patients age \> =18 who have been diagnosed with multiple myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (ahsct) will be screened for eligibility. patients must fulfill all of the following inclusion criteria to be eligible for this study: 1. diagnosis of multiple myeloma 2. age \>=18 and no more than 70 years. 3. able to understand and sign a consent form. 4. can collect peripheral blood stem cells with a cd34+ cell dose of at least 5.0 x 106/kg. the cd34 molecule is a cluster of differentiation molecule present on hematopoietic stem cells. 5. conditioning regimen to be high dose melphalan at a dose of 200mg/m2. 6. karnofsky performance score (kps) \>60 or ecog (eastern cooperative oncology group) performance status \<=2 7. kidney function:creatinine \ 50 ml/min 8. heart function: ejection fraction \>45% 9. liver function tests :serum bilirubin, alanine aminotransferase (alt), aspartate aminotransferase (ast) less than 3 x upper limit of normal 10. lung function tests: forced vital capacity (fvc), forced expiratory volume in one second (fev1) or diffusing capacity of the lung for carbon monoxide (dlco) \>45% predicted exclusion criteria: 1. age \ 70 years 2. previous exposure to denileukin diftitox. 3. patients with documented uncontrolled central nervous system (cns) disease. 4. previous ahsct. 5. significant organ dysfunction deemed to be inappropriate for autologous transplantation.
comparing the effectiveness of shotokan-karate vs. tai chi on balance and quality of life in parkinson's disease

Conditions: Parkinson Disease

Summary: the following study will be a comparison of balance and quality of life in tai chi training programs and shotokan-karate training programs in individuals with parkinson's disease. the following study will be a 12-week program which will assess whether or not shotokan-karate betters balance and quality of life even more than tai chi. both tai chi and karate will be taught by a professional instruction at the sun life financial movement disorders and rehabilitation centre located in waterloo, ontario.

parkinson's disease is a progressive disorder of the central nervous system which affects movement. some signs and symptoms of pd include; tremors, rigidity, gait impairments, and balance disruption. individuals with pd experience substantially impaired balance ultimately affecting their functional abilities. with this, individuals with pd may also experience lower quality of life due to these diminished determinants. currently, there are medications which have proven to mask the symptoms of parkinson's such as levodopa. there are also exercise programs which have proven to improve the symptoms of parkinson's disease such as resistance based exercises and tai chi.based on the proven benefits of balance and overall quality of life through shotokan-karate training, the purpose of this study will be to compare shotokan-karate training versus tai chi on balance and quality of life in individuals with parkinson's disease. based on the literature available on the benefits of shotokan-karate on balance and quality of life in the elderly, it is hypothesized that shotokan-karate will improve balance and quality of life due to its high intensity, increased engagement and similarities to everyday movements. if the following hypothesis is supported, the present study will allow for individuals with parkinson's disease to engage in an exercise program that shows vast improvements in their postural stability and overall quality of life. in addition, participants will be able to engage in an exercise program which will provide them with long term benefits and they will be able to implement this in their everyday lifestyle.

Eligibility criteria:
inclusion criteria: * eligibility criteria involved a clinical diagnosis of parkinson's disease, stable medication use, ability to comprehend english, ability to stand without aid and walk with or without assisted aids. exclusion criteria: * exclusion criteria for participating in this study included any participation in current studies, which involve behavioural, cognitive or pharmacological interventions. in addition, individuals with impaired vision, impaired behavioural and cognitive abilities, and those who are unable to participate in this study due to unavailability and those with scheduling conflicts will also be apart of the exclusion criteria.
walnuts for power: polyphenols, omega-3 fatty acids, weight loss, and energy

Conditions: Prostate Cancer

Summary: this is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo rp. patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for rp.

the overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by ki67 expression in the prostate tissues. subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. the baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (rp), and the final visit will occur in conjunction with a standard of care visit prior to rp.

Eligibility criteria:
inclusion criteria: * pathologically confirmed prostate adenocarcinoma. * diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location. * biopsy grade group 2 or higher (gleason ≥7). * planning to undergo rp. * willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day. * reads, writes, and understands english. * age 18 or older exclusion criteria: * allergy to nuts. * history of receiving hormone therapy or antiandrogen therapy. * use of 5-alpha reductase inhibitors in the past 6 months. * prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy. * currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil). * other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma * significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible. * individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.

Keywords: prostate cancer prostate adenocarcinoma diet walnuts radical prostatectomy omega-3 fatty acids polyphenols